Isoray, Inc. (NYSE AMERICAN: ISR), a medical technology company and
innovator in seed brachytherapy powering expanding treatment
options throughout the body, today announced its financial results
for the first quarter fiscal 2022 ended September 30, 2021.
Revenue for the first quarter of fiscal 2022 grew 8% to $2.56
million versus $2.38 million in the prior year comparable period.
The company’s core prostate brachytherapy revenue increased 4%
versus the first quarter of fiscal 2021. Prostate brachytherapy
represented 77% of total revenue for the first quarter of fiscal
2022 compared to 79% in the prior year comparable period.
Non-prostate brachytherapy revenue increased 20% versus the prior
year comparable period. The majority of non-prostate brachytherapy
revenue in the quarter was comprised of sales to treat brain
cancer, including sales of GammaTile® Therapy.
Gross profit as a percentage of revenues was 40.1% for the three
months ended September 30, 2021 versus 52.3% in the prior year
comparable period. First quarter gross profit decreased 17% to
$1.03 million versus $1.25 million in the first quarter of fiscal
2021, as the year over year sales growth was offset by increased
costs of goods sold primarily as the result of greater isotope and
non-isotope material costs as well as increased payroll and
benefits expense due to the increase in headcount versus the prior
year comparable period.
Isoray CEO Lori Woods said, “We are encouraged by the prospects
for our core prostate brachytherapy business which grew year over
year again this quarter. As our innovation pipeline continues to
evolve, we are taking what we believe are important steps critical
to support the scaling of the organization in anticipation of
future growth in our core prostate brachytherapy market as well as
in markets related to hard-to-treat cancers.”
Total operating expenses increased 69% in the first quarter to
$3.30 million from $1.96 million in the prior year
period. Total research and development expenses increased 125%
versus the prior year comparable period. The increase in research
and development expenses was primarily the result of increased
payroll and benefits expense due to greater headcount, increased
share-based stock compensation expense due to a timing shift in
annual employee stock grants, and higher market research expenses
versus the prior year comparable period.
Sales and marketing expenses increased 31% versus the prior year
comparable period. The increase in sales and marketing expenses was
driven primarily by increases in travel and tradeshow costs and
increased share-based stock compensation expense due to a timing
shift in annual employee stock grants versus the prior year
comparable period. General and administrative expenses increased
72% versus the prior year comparable period. The increases in
general and administrative expenses were primarily the result of
increased payroll and benefits expense due to annual merit
increases and greater headcount, increased employment hiring
expenses, and increased share-based stock compensation expense due
to a timing shift in annual employee and director stock grants
versus the prior year comparable period.
The net loss for the three months ended September 30, 2021 was
$2.24 million or ($0.02) per basic and diluted share versus a net
loss of $0.71 million or ($0.01) per basic and diluted share
in the comparable prior year period. Basic and diluted per share
results are based on weighted average shares outstanding of
approximately 141.9 million for the three months ended September
30, 2021 versus 68.9 million in the comparable prior year
period.
Cash, cash equivalents, and certificates of deposit at the end
of the first quarter of fiscal 2022 totaled $61.7 million and the
company had no debt. Stockholders’ equity at the end of the first
quarter of fiscal 2022 totaled $65.8 million.
Conference Call DetailsThe company will hold an
earnings conference call today, November 10, at 4:30 p.m. ET/1:30
p.m. PT to discuss operating results. To listen to the conference
call, please dial (888) 506-0062. For callers outside the U.S.,
please dial (973) 528-0011.
The conference call will be simultaneously webcast and can be
accessed
at https://www.webcaster4.com/Webcast/Page/2199/43432. The
webcast will be available until February 10, 2022 following the
conference call.
ContactsInvestor Relations: Mark Levin (501)
255-1910Media and Public Relations: Sharon Schultz (302)
539-3747
About IsorayIsoray, Inc. is a medical
technology company pioneering advanced treatment applications and
devices to deliver targeted internal radiation treatments for
cancers throughout the body. Isoray, Inc., through its subsidiary,
Isoray Medical, Inc., is the sole producer of Cesium-131
brachytherapy seeds. Learn more about this innovative Richland,
Washington company and explore the many benefits and uses of
Cesium-131 by visiting www.isoray.com. Follow us on LinkedIn and
Twitter.
Safe Harbor StatementStatements in this news
release about Isoray’s future expectations, including: the
anticipated continued growth in revenues in fiscal year 2022, the
impact of COVID-19 on our financial results, timing of recovery in
our brachytherapy procedures, suppliers, scheduling of procedures,
and employees, advantages of our products including Blu Build and
the GammaTile Therapy delivery system, whether interest in and use
of our Cesium-131, commercially known as Cesium Blu, products will
increase or continue, whether use of Cesium-131 in non-prostate
applications will continue to increase revenue, whether research
and development we conduct will result in viable revenue
opportunities, whether our market presence and growth will
continue, and all other statements in this release, other than
historical facts, are “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995
(“PSLRA”). This statement is included for the express purpose of
availing Isoray, Inc. of the protections of the safe harbor
provisions of the PSLRA. It is important to note that actual
results and ultimate corporate actions could differ materially from
those in such forward-looking statements based on such factors as
physician acceptance, training and use of our products, market
acceptance and recognition of our products, our ability to
successfully manufacture, market, and sell our Blu Build products
and the success of the GammaTile Therapy, the length and severity
of the COVID-19 pandemic, our ability to manufacture our products
in sufficient quantities to meet demand within required delivery
time periods while meeting our quality control standards, our
ability to enforce our intellectual property rights, whether
additional studies are released that support the conclusions of
past studies, whether ongoing patient results with our products are
favorable and in line with the conclusions of clinical studies and
initial patient results, patient results achieved when our products
are used for the treatment of cancers and malignant diseases,
successful completion of future research and development
activities, whether we, our distributors and our customers will
successfully obtain and maintain all required regulatory approvals
and licenses to market, sell and use our products in its various
forms, continued compliance with ISO standards, the success of our
sales and marketing efforts, changes in reimbursement rates, the
procedures and regulatory requirements mandated by the FDA for
510(k) approval and reimbursement codes, changes in laws and
regulations applicable to our products, the scheduling of
physicians who either delay or do not schedule patients in periods
anticipated, the use of competitors’ products in lieu of our
products, less favorable reimbursement rates than anticipated for
each of our products, and other risks detailed from time to time in
Isoray’s reports filed with the SEC. Unless required to do so by
law, we undertake no obligation to publicly update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Isoray, Inc. and
Subsidiaries |
Consolidated Balance
Sheets (Unaudited) |
(In thousands, except
shares) |
|
|
September 30, |
|
|
June 30, |
|
|
|
2021 |
|
|
2021 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
61,690 |
|
|
$ |
63,828 |
|
Accounts receivable, net |
|
|
1,902 |
|
|
|
2,013 |
|
Inventory |
|
|
1,060 |
|
|
|
980 |
|
Prepaid expenses and other current assets |
|
|
306 |
|
|
|
481 |
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
64,958 |
|
|
|
67,302 |
|
|
|
|
|
|
|
|
|
|
Property and equipment,
net |
|
|
1,953 |
|
|
|
1,958 |
|
Right
of use asset, net |
|
|
705 |
|
|
|
768 |
|
Restricted cash |
|
|
182 |
|
|
|
182 |
|
Inventory, non-current |
|
|
792 |
|
|
|
76 |
|
Other assets, net |
|
|
120 |
|
|
|
130 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
68,710 |
|
|
$ |
70,416 |
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
768 |
|
|
$ |
730 |
|
Lease liability |
|
|
256 |
|
|
|
252 |
|
Accrued protocol expense |
|
|
120 |
|
|
|
98 |
|
Accrued radioactive waste disposal |
|
|
102 |
|
|
|
100 |
|
Accrued payroll and related taxes |
|
|
300 |
|
|
|
362 |
|
Accrued vacation |
|
|
253 |
|
|
|
259 |
|
|
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
1,799 |
|
|
|
1,801 |
|
Non-current liabilities: |
|
|
|
|
|
|
|
|
Lease liability, non-current |
|
|
459 |
|
|
|
524 |
|
Accrued payroll and related taxes, non-current |
|
|
77 |
|
|
|
77 |
|
Asset retirement obligation |
|
|
616 |
|
|
|
608 |
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
2,951 |
|
|
|
3,010 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
|
|
Common stock, $.001 par value; 200,000,000 shares authorized;
141,915,266 and 141,915,266 shares issued and outstanding |
|
|
142 |
|
|
|
142 |
|
Additional paid-in capital |
|
|
159,185 |
|
|
|
158,589 |
|
Accumulated deficit |
|
|
(93,568 |
) |
|
|
(91,325 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders' equity |
|
|
65,759 |
|
|
|
67,406 |
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
|
$ |
68,710 |
|
|
$ |
70,416 |
|
Isoray, Inc. and
Subsidiaries |
Consolidated
Statements of Operations (Unaudited) |
(Dollars and shares in
thousands, except for per-share amounts) |
|
|
Quarter ended September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
Sales, net |
|
$ |
2,564 |
|
|
$ |
2,384 |
|
Cost of sales |
|
|
1,535 |
|
|
|
1,138 |
|
Gross profit |
|
|
1,029 |
|
|
|
1,246 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
702 |
|
|
|
312 |
|
Sales and marketing |
|
|
761 |
|
|
|
581 |
|
General and administrative |
|
|
1,840 |
|
|
|
1,067 |
|
Total operating expenses |
|
|
3,303 |
|
|
|
1,960 |
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
|
(2,274 |
) |
|
|
(714 |
) |
|
|
|
|
|
|
|
|
|
Non-operating income: |
|
|
|
|
|
|
|
|
Interest income, net |
|
|
31 |
|
|
|
1 |
|
Non-operating income, net |
|
|
31 |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
|
Net loss |
|
|
(2,243 |
) |
|
|
(713 |
) |
Preferred stock dividends |
|
|
- |
|
|
|
(3 |
) |
|
|
|
|
|
|
|
|
|
Net loss applicable to common stockholders |
|
$ |
(2,243 |
) |
|
$ |
(716 |
) |
|
|
|
|
|
|
|
|
|
Basic and diluted loss per
share |
|
$ |
(0.02 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
Weighted average shares used
in computing net loss per share: |
|
|
|
|
|
|
|
|
Basic and diluted |
|
|
141,915 |
|
|
|
68,898 |
|
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